The Effects of Tirzepatide on Coronary Plaque Lipid Content and Myocardial Microvascular Function in Overweight and Obese People With Coronary Disease - The IDEAL-COR Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The objective of this study is to investigate, as a proof-of-principle, long-term (52 weeks) effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression (assessed by NIRS), plaque burden (assessed by IVUS) and microvascular function (assessed by invasively measured CFR) in overweight and obese individuals with stable coronary artery disease (CAD). In addition, the objective of a baseline cross-sectional sub-study is to explore potential metabolic and cardiovascular (CV) predictors for high arteriosclerotic plaque burden in overweight and obese individuals and to establish a cohort for future research projects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Informed written consent

• BMI equal to or above 27 kg/m2

• Age 18 years or older

• Referred to coronary angiogram (CAG) due to stable angina

• Coronary atheromatosis by angiography (obstructive or non-obstructive)

• LCBI4mm \>200 by NIRS in a vessel not subjected to coronary intervention

Locations
Other Locations
Denmark
Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Gentofte Hospital
RECRUITING
Gentofte Municipality
Steno Diabetes Center Copenhagen
RECRUITING
Herlev
Contact Information
Primary
Daniel Raaschou-Oddershede, MD
daniel.raaschou-oddershede@regionh.dk
+4520157448
Backup
Christine Rode Schwarz, MD, PhD
christine.rode.schwarz@regionh.dk
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 124
Treatments
Experimental: Tirzepatide
Tirzepatide is administered sc. once-weekly.
Placebo_comparator: Placebo
Placebo is administered sc. once-weekly.
Sponsors
Leads: Tina Vilsbøll

This content was sourced from clinicaltrials.gov